Company* (Country; Symbol) |
Product |
Description |
Indication |
Status (Date) |
AUTOIMMUNE | ||||
Biogen Idec Inc. (BIIB) and Elan Corp. plc (Ireland) |
Antegren (natalizumab) |
Humanized monoclonal antibody; alpha-4 antagonist in the selective adhesion molecule inhibitor class |
Multiple sclerosis |
Filed BLA with the FDA following decision in February to file on one- ear data on 2,100 patients instead of two-year data; the trial will continue, so results were not disclosed (5/25) |
CANCER | ||||
Allos Therapeutics Inc. (ALLP) |
RSR13 (efaproxiral) |
Small molecule designed to sensitize hypoxic areas of tumors prior to radiation |
Brain metastases |
FDA advisory panel recommended against approving the product for treating patients with metastases originating from breast cancer (5/3) |
American BioSciences Inc.* |
Abraxane |
Nanoparticle albuminbound taxane |
Metastatic breast cancer |
The FDA accepted for filing the NDA on Abraxane, which was submitted in March (5/10) |
Cell Genesys Inc. (CEGE) |
GVAX |
Whole-cell vaccine comprised of tumor cells irradiated and modified to secrete GM-CSF |
Prostate cancer |
Received a special protocol assessment from the FDA for upcoming Phase III trial in hormone-refractory, metastatic disease (5/10) |
Favrille Inc.* |
FavId |
Vaccine designed to stimulate immune responses |
Non-Hodgkin's lymphoma |
Got FDA special protocol assessment for upcoming Phase III trial to use product after Rituxan treatment in patients with follicular B-cell NHL; trial is expected to start in3Q:04 (5/19) |
Genta Inc. (GNTA) andAventis SA (France) |
Genasense |
Oblimersen sodium; inhibits function of bcl-2 protein |
Advanced melanoma |
FDA advisory panel said drug and dacarbazine failed to demonstrate effectiveness vs. dacarbazine alone (5/3); companies terminated expanded access program for the drug (5/28) |
Inex Pharmaceuticals Corp. (Canada; TSE:IEX) and Enzon Pharmaceuticals Inc. (ENZN) |
Onco TCS |
Vincristine encapsulated in Inex's TCS (liposomal) drug delivery technology |
Relapsed, aggressive non- Hodgkin's lymphoma |
The FDA accepted the NDA for the product and designated it for standard review (5/21) |
Pharmion Corp. (PHRM) |
Vidaza |
Azacitidine for injectable suspension; believed to have demethylation and cytotoxic actions |
Myelodysplastic syndromes |
The FDA approved the drug for all five MDS subtypes; the drug has orphan status in the U.S. (5/19) |
Progen Industries Ltd. (Australia; ASX:PGL) |
Pi-88 |
Anti-angiogenesis drug also is designed to inhibit tumor-promoting factors |
Malignant melanoma |
FDA granted orphan designation to the product in that indication (5/3) |
Therion Biologics Corp.* |
Panvac-VF |
Vaccine designed to stimulate the immune system to target and destroy cells expressing CEA and mucin-1 |
Metastatic pancreatic cancer |
Reached agreement with FDA under special protocol assessment for pivotal Phase III trial in 250 patients who have failed gemcitabine treatment (5/24) |
Xenova Group plc (UK; XNVA) |
TransMID |
Modified diphtheria toxin conjugated to transferrin |
Glioblastoma multiforme |
Reached agreement with FDA under special protocol assessment to run two smaller Phase III trials rather than one large study; the first trial will have 323 patients (5/11) |
CARDIOVASCULAR | ||||
Dyax Corp. (DYAX) |
DX-88 |
Recombinant small protein designed to inhibit human plasma kallikrein |
Hereditary angioedema |
The FDA put a hold on the clinical program, which is in Phase II, until resolution of questions regarding preclinical animal studies (5/25) |
Inotek Pharmaceuticals Corp.* |
INO-1001 |
Inhibitor of the nuclear cell death enzyme (ADP-ribose) polymerase |
Thoraco- abdominal aortic aneurysm |
The FDA designated it a fast- track product for complications associated with TAAA repair surgery; the drug is nearing Phase II (5/24) |
CENTRAL NERVOUS SYSTEM | ||||
Endo Pharmaceuticals Inc. (ENDP) and SkyePharma plc (UK; SKYE) |
DepoDur (previously named DepoMorphine) |
Sustained-release, injectable liposomal formulation of morphine |
Post-surgical pain |
The FDA approved the product for treating pain following major surgery; launch is expected by the end of the year (5/19) |
Endo Pharmaceuticals Inc. (ENDP) |
Oxymorphone |
Entended-release formulation of oxymorphone |
Pain |
Company will initiate a new trial to provide additional data; decision followed meeting with FDA, which issued approvable letter in October 2003 calling for more study (5/6) |
Phase 2 Discovery Inc.* |
PD-6735 |
Melatonin analogue; agonist at melatonin-1 and melatonin-2 receptors |
Circadian sleep disorders |
The FDA granted orphan designation to the product in treating the disorders in blind individuals (5/26) |
INFECTION | ||||
Gilead Sciences Inc. (GILD) |
Viread and Emtriva (both FDA-approved) |
Nucleotide and nucleoside reverse transcriptase inhibitors, respectively |
HIV |
The FDA granted priority review to NDA on the fixed-dose co-formulation of the drugs; the NDA was filed in March (5/17) |
Octapharma AG* (Switzerland) |
Octagam |
Liquid solvent/detergent- treated immunoglobulin intravenous (IGIV) product |
Primary immunodeficiency diseases |
The FDA granted the product approval in that indication; it has been available in Europe for 10 years (5/24) |
Sinovac Biotech Inc.* (China; OTC BB:SNVBF) |
-- |
Vaccine for severe acute respiratory syndrome |
SARS |
Began trial in healthy volunteers in Beijing; said no abnormal reactions resulted from first four inoculations (5/23) |
Vicuron Pharmaceuticals Inc. (MICU) |
Anidulafungin |
Broad-spectrum agent from the echinocandin class |
Esophageal candidiasis |
FDA issued approvable letter stating NDA does not support approval; agency said approval could be possible after completion of ongoing Phase III trial (5/24) |
MISCELLANEOUS | ||||
Adolor Corp. (ADLR) and GlaxoSmithKline plc (UK) |
Entereg (alvimopan) |
Mu opioid antagonist |
Post-operative ileus |
Adolor submitted the first portion of its NDA for Entereg, which has fast-track status (5/7) |
Indevus Pharmaceuticals Inc. (IDEV) |
Sanctura (trospium chloride) |
Quarternary ammonium anticholinergic compound; muscarinic receptor antagonist |
Overactive bladder |
The FDA approved the product, which already is sold in Europe and will be co- promoted by Pliva d.d. (5/28) |
Isolagen Inc. |
Isolagen Process |
Autologous cellular therapy |
Nasolabial folds and glabellar lines |
Reached agreement with the FDA on special protocol assessment covering two pivotal Phase IIIstudies (5/23) |
ISTA Pharmaceuticals Inc. (ISTA) |
Xibrom |
Bromfenac sodium solution; topical non-steroidal anti-inflammatory agent |
Ocular inflammation following cataract surgery |
Filed NDA with the FDA seeking approval in that indication (5/25) |
ISTA Pharmaceuticals Inc. (ISTA) |
Vitrase |
Ovine hyaluronidase formulation |
Spreading agent |
The FDA approved the agent for use as a spreading agent to facilitate the dispersion and absorption of other drugs (5/6) |
Notes: | ||||
* Privately held | ||||
Unless otherwise noted, the stock symbols listed for public companies are on the Nasdaq market. | ||||
AMEX = American Stock Exchange; ASX = Australian Stock Exchange. | ||||
